Drugs / RN0191
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06132360 | Jan → Jul 2024 | combined low LDL and fibrinogen | Shanghai Rona Therapeutics Co., Ltd. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05905068 Comparator | Jul 2023 → Feb 2024 | hyperlipidemia, combined, 2 | Ikaria Bioscience Pty Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-11-15 | Shanghai Rona Therapeutics Co., Ltd. | Results Rona Therapeutics Presented Positive Phase 1 Results of RN0191, a Novel siRNA Therapy Targeting PCSK9, at the 2024 American Heart Association (AHA) Scientific Sessions ronatherapeutics.com ↗
Dose-dependent, significant and durable changes in PCSK9, LDL-C and other lipid parameters were observed (see table below). |
| 2023-12-29 | Shanghai Rona Therapeutics Co., Ltd. | Regulatory Rona Therapeutics's First Self-developed siRNA Product has been Approved for Conducting Clinical Trial in China ronatherapeutics.com ↗
On December 29, 2023, Rona Therapeutics's first independently developed RN0191 injection has successfully obtained the implicit license for clinical trial application approved by the National Medical Products Adminstration. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-15 | Shanghai Rona Therapeutics Co., Ltd. | Rona Therapeutics Presented Positive Phase 1 Results of RN0191, a Novel siRNA Therapy Targeting PCSK9, at the 2024 American Heart Association (AHA) Scientific Sessions ronatherapeutics.com ↗ |
| 2023-12-29 | Shanghai Rona Therapeutics Co., Ltd. | Rona Therapeutics's First Self-developed siRNA Product has been Approved for Conducting Clinical Trial in China ronatherapeutics.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RN0191 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05905068 ↗ |
| Route | Subcutaneous | “RN0191 administered SC to adult subjects with elevated low-density lipoprotein-cholesterol.” NCT05905068 ↗ |